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FDA 510(k)

OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS

K-Number: K123501 · 2013-02-27

ApplicantBiomet, Inc.
Decision Date2013-02-27
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2013-02-27 under 510(k) number K123501. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS?

OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS is a medical device that received FDA 510(k) clearance on 2013-02-27. The listed applicant is Biomet, Inc.. The 510(k) number is K123501.

When did OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS receive FDA 510(k) clearance?

OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS received FDA 510(k) clearance on 2013-02-27, under 510(k) number K123501.

Who is the listed applicant for OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS?

The FDA 510(k) record lists Biomet, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS?

The FDA product code for OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS is JDI.

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Other records listing Biomet, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253434OSSTM Orthopedic Salvage SystemK251270Taperloc® Complete Hip StemK241014Biomet Kirschner Wires (K-Wires)K222760StageOne™ Select Hip Cement Spacer MoldsK221968StageOne™ Shoulder Cement Spacer MoldsK213287StageOne Knee Cement Spacer Molds

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Related Devices (Code: JDI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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